CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)

Type 1 Diabetes Mellitus Clinical Trial

— CITY  

Official title:

CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-<25 With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263494
• Other study ID #: CITY
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2018
• Est. completion date: November 7, 2019

Study information

• Verified date: March 2020
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 7, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of T1D, with either age of T1D diagnosis < 10 years of age OR a history of positive T1D related antibodies in the medical record

2. Age 14-<25 years

3. Diabetes duration = 1 year

4. Total daily insulin requirement = 0.4 units/kg/day

5. HbA1c 7.5% to <11.0% (Point of care device or local lab measured as part of study at screening visit)

6. Insulin regimen involves a consistent modality of insulin administration with either use of an insulin pump or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin. Insulin pump must not have been started within 3 months of consent with no plans to change regimens in the next 6 months

7. Perform at least 2 blood glucose meter checks per day from self-report at screening and an average of at least 2 checks per day from meter download during blinded CGM run in

8. Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an average of 1.8 calibrations per day during the blinded CGM screening period.

9. Participant comprehends written and spoken English

10. Participant understands the study protocol and agrees to it (if applicable)

Exclusion Criteria:

1. Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part of real-time diabetes management in the last 3 months

2. Unable to use CGM device for minimum number of hours during blinded pre-randomization period or skin reaction from adhesive that would preclude participation in the randomized trial

3. Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months

4. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors (such as a skin condition), or the completion of any aspect of the protocol.

5. More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.

6. The presence of any of the following diseases:

• Asthma or any condition present in the last 6 months where treatment is a systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)

• Cystic fibrosis

• Addison's disease (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)

7. Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.

8. Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.

9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial

10. Participation in a diabetes related intervention study in the past 6 weeks.

11. Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention

12. Any condition, per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin administration within 3 months prior to screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitor (CGM)
Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.

Locations

Country	Name	City	State
United States	Barbara Davis Center--University of Colorado	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Rocky Mountain Diabetes & Osteoporosis Center	Idaho Falls	Idaho
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Naomi Berrie Diabetes Center at Columbia University	New York	New York
United States	Stanford University	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	IDC at Park Nicollet	Saint Louis Park	Minnesota
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to 26 weeks adjusted for baseline		6 months
Secondary	% with HbA1c <7.0%		6 months
Secondary	% with HbA1c <7.5%		6 months
Secondary	% with relative reduction = 10%		6 months
Secondary	% with absolute reduction = 0.5%		6 months
Secondary	% with absolute reduction = 1%		6 months
Secondary	% with absolute reduction = 1% or HbA1c < 7.0%		6 months
Secondary	CGM % time in range 70-180 mg/dl		6 months
Secondary	CGM mean glucose		6 months
Secondary	CGM glucose variability measured by coefficient of variation		6 months
Secondary	CGM % time > 180 mg/dl		6 months
Secondary	CGM % time > 300 mg/dl		6 months
Secondary	CGM % time < 54 mg/dl		6 months
Secondary	CGM % time < 70 mg/dl		6 months
Secondary	Rate of CGM measured hypoglycemic episodes (using <54 mg/dL)		6 months
Secondary	CGM Self Efficacy Questionnaire Score	Questionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability.	6 months
Secondary	Problem Areas in Diabetes (PAID) Questionnaire Score	Survey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem.	6 months
Secondary	Glucose Monitoring Satisfaction Questionnaire Score	Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.	6 months
Secondary	Hypoglycemia Confidence Questionnaire Score	Survey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence.	6 months
Secondary	Diabetes Technology Attitudes Questionnaire Score	Survey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology.	6 months
Secondary	Pittsburgh Sleep Quality Index	Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.	6 months